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The Masimo Compatible Saturation Module, E-MASIMO, and accessories are indicated for monitoring arterial oxygen saturation and pulse rate of hospitalized patients. The device is indicated for use by qualified medical personnel only.

The Masimo Compatible Saturation Module, E-MASIMO, is a single-width plug-in parameter module for a S/5 Modular Monitoring system. The Masimo Compatible Saturation Module, E-MASIMO is used for measuring noninvasive arterial oxygen saturation (SpO2) and pulse rate of hospitalized patients. The SpO2 measurement is based on light transillumination and is made optically with an infrared light and a red light sources and a photosensitive detector. The SpO2 value and pulse rate are calculated based on the signals, which are measured with the photosensitive detector in the SpO2 sensor.

The Masimo Compatible Saturation Module, E-MASIMO consists of an electronic measurement board based on MasimoSET® technology (OEM from Masimo Inc.), an interface board and connector flex board designed by GE Healthcare Finland Oy (former Datex-Ohmeda Div) for connecting the Masimo measurement board to a Datex-Ohmeda S/5 modular monitor.

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device for a Masimo Compatible Saturation Module (E-MASIMO), rather than presenting a study to prove the device meets specific performance acceptance criteria through clinical trials or extensive validation. The submission primarily relies on a comparative approach, asserting that the new device is as safe and effective as its predicate. Therefore, much of the requested information regarding acceptance criteria, study sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML-based diagnostic devices, is not explicitly available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Specific numerical acceptance criteria and a detailed table of device performance against these criteria are not provided in this 510(k) summary. The submission states that the device "complies with the voluntary standards as detailed in Section 4.2 Specific Standards and Guidance of this submission," but these standards and their specific requirements are not included in the provided text.

The conclusion states: "The results of these tests and analysis demonstrated that the Masimo Compatible Saturation Module, E-MASIMO is as safe, as effective, and performs as well as the predicate device." This is a general statement of equivalence, not a report of specific performance metrics against pre-defined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify any sample size for a test set or data provenance (e.g., country of origin, retrospective or prospective) for performance evaluation. The "Test Summary" lists various quality assurance measures (risk analysis, requirements reviews, design reviews, subsystem verification, integration testing, final acceptance testing, performance testing, safety testing, environmental testing), but these appear to be related to engineering and manufacturing quality rather than specific clinical performance validation studies with defined test sets.

Given the nature of the device (a saturation module based on existing MasimoSET® technology integrated into GE Healthcare monitors), the performance is likely assumed to be inherited from the proven MasimoSET® technology and the predicate device, with the primary focus of this submission being the integration and compatibility.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable and not mentioned. This type of information is typically required for diagnostic devices where human expert interpretation is the gold standard. For a pulse oximeter module, the "ground truth" for SpO2 measurements would typically be derived from co-oximetry, not expert visual assessment. However, no such detailed clinical study is described here.

4. Adjudication Method for the Test Set

Not applicable and not mentioned. As there's no described test set requiring human interpretation, no adjudication method would be in place.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done or described. This type of study is relevant for imaging or diagnostic tools where human readers interpret results, sometimes with AI assistance. The E-MASIMO is a measurement device (pulse oximeter module), not an interpretative diagnostic system.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is a standalone module designed to run an algorithm (MasimoSET® technology) for SpO2 and pulse rate measurement. Therefore, its performance is inherently a "standalone" or "algorithm only" performance within the context of hardware integration. However, the document does not present a specific standalone performance study in terms of accuracy metrics against reference standards. It relies on the equivalence to the predicate device and the underlying MasimoSET® technology.

7. The Type of Ground Truth Used

Not explicitly stated for any formal clinical validation study. For pulse oximetry, the gold standard (ground truth) for oxygen saturation is typically arterial blood gas analysis with co-oximetry. However, this 510(k) summary is not detailing a de novo clinical validation study against such a ground truth. It assumes the underlying MasimoSET® technology has already established its accuracy, and the focus is on the integration and compatibility.

8. The Sample Size for the Training Set

Not applicable and not mentioned. This device is not an AI/ML system that requires a "training set" in the conventional sense of machine learning algorithms. It is a hardware module incorporating a pre-existing signal processing technology (MasimoSET®).

9. How the Ground Truth for the Training Set Was Established

Not applicable and not mentioned for the same reasons as above.

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